FDA 510(k)

嗨多無線電擊療/電動肌肉刺激系統（型號 HD-5N）

K 號：K163393 · 2017-08-04

決定日期2017-08-04

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Hi-Dow Wireless TENS/EMS System (Model HD-5N) is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2017-08-04 under 510(k) number K163393. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hi-Dow Wireless TENS/EMS System (Model HD-5N)?

Hi-Dow Wireless TENS/EMS System (Model HD-5N) is a medical device that received FDA 510(k) clearance on 2017-08-04. The listed applicant is Hi-Dow International, Inc.. The 510(k) number is K163393.

When did Hi-Dow Wireless TENS/EMS System (Model HD-5N) receive FDA 510(k) clearance?

Hi-Dow Wireless TENS/EMS System (Model HD-5N) received FDA 510(k) clearance on 2017-08-04, under 510(k) number K163393.

Who is the listed applicant for Hi-Dow Wireless TENS/EMS System (Model HD-5N)?

The FDA 510(k) record lists Hi-Dow International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hi-Dow Wireless TENS/EMS System (Model HD-5N)?

The FDA product code for Hi-Dow Wireless TENS/EMS System (Model HD-5N) is NUH.

其他以 Hi-Dow International, Inc. 為申請人之記錄

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相關器械（代碼：NUH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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